NCT04059250|CompletedResultsFDA Device
Nobio Clinical Study - Demineralization Prevention With a New Antibacterial Restorative Composite
Nobio
Nobio In Situ Clinical Study - Pilot Study
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Sponsor study identifier
interventional
25
1 country
1
Study Start
May 28, 2019
Actual (reported)Primary Completion
March 10, 2020
Actual (reported)Study Completion
March 10, 2020
Actual (reported)Nobio has developed dental restorative materials with long term antibacterial properties in order to fight recurrent decay/caries around restorations. These composites with incorporated non-leaching antibacterial agents might overcome the vicious circle of newly developed cavities around freshly placed fillings. The investigators will ask lower partial denture wearers to allow them to place a "gap model" with the Nobio-composite and enamel slab in one denture flange. In the other denture flange a gap model with a standard composite will be placed as control. In the laboratory the investigators will test with established methods for demineralization/caries prevention in the test and control enamel slabs, respectively.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 10, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 28, 2019
Actual (reported)August 14, 2019
Actual (reported)August 16, 2019
Actual (reported)March 10, 2020
Actual (reported)March 10, 2020
Actual (reported)March 12, 2021
Actual (reported)Mineral Loss ΔZ
The mineral loss is determined in the laboratory using cross-sectional microhardness testings of the enamel after the 4-weeks wearing period of the gap-model. The overall relative mineral loss, ΔZ, for each sample is calculated by creating a hardness profile curve by plotting normalized volume percent mineral against distance from the outer enamel surface. The area under the curve that represents ΔZ (µm \* vol % mineral) is calculated using Simpson's integration rule.
mineral loss ΔZ is determined after the 4 week wearing period
On the Nobio flange side of the lower partial denture the gap model will include a double sterilized piece of human enamel, a small gap, and next to it the Nobio composite.
On the traditional composite flange side of the lower partial denture the gap model will include a double sterilized piece of human enamel, a small gap, and next to it a traditional composite.
Nobio has developed a bactericidal composite, which does not leak out the bactericidal nano fillers
traditional composite which has no bactericidal activities
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
UCSF School of Dentistry, Preventive and Restorative Dental Sciences
San Francisco, California, 94143, United States
Clasen AB, Ogaard B. Experimental intra-oral caries models in fluoride research. Acta Odontol Scand. 1999 Dec;57(6):334-41. doi: 10.1080/000163599428580.
Zero DT. In situ caries models. Adv Dent Res. 1995 Nov;9(3):214-30; discussion 231-4. doi: 10.1177/08959374950090030501.
Gorton J, Featherstone JD. In vivo inhibition of demineralization around orthodontic brackets. Am J Orthod Dentofacial Orthop. 2003 Jan;123(1):10-4. doi: 10.1067/mod.2003.47.
Peter Rechmann
UCSF - School of Dentistry - Preventive and Restorative Dental Sciences
25 participants (actual enrollment reported by the registry).
First Submitted
August 14, 2019
First Posted
August 16, 2019
Remineralization Effects of Hydroxyapatite Toothpaste
Contact the study team to confirm eligibility.
Maupome G, Sheiham A. Criteria for restoration replacement and restoration life-span estimates in an educational environment. J Oral Rehabil. 1998 Dec;25(12):896-901. doi: 10.1046/j.1365-2842.1998.00328.x.
Kidd EA. Diagnosis of secondary caries. J Dent Educ. 2001 Oct;65(10):997-1000.
Hals E, Nernaes A. Histopathology of in vitro caries developing around silver amalgam fillings. Caries Res. 1971;5(1):58-77. doi: 10.1159/000259733. No abstract available.
Kuper NK, Montagner AF, van de Sande FH, Bronkhorst EM, Opdam NJ, Huysmans MC. Secondary Caries Development in in situ Gaps next to Composite and Amalgam. Caries Res. 2015;49(5):557-63. doi: 10.1159/000438728. Epub 2015 Sep 26.
Hollanders ACC, Kuper NK, Maske TT, Huysmans MDNJM. Secondary Caries in situ Models: A Systematic Review. Caries Res. 2018;52(6):454-462. doi: 10.1159/000487200. Epub 2018 Apr 5.
Benelli EM, Serra MC, Rodrigues AL Jr, Cury JA. In situ anticariogenic potential of glass ionomer cement. Caries Res. 1993;27(4):280-4. doi: 10.1159/000261551.
Dijkman GE, Arends J. Secondary caries in situ around fluoride-releasing light-curing composites: a quantitative model investigation on four materials with a fluoride content between 0 and 26 vol%. Caries Res. 1992;26(5):351-7. doi: 10.1159/000261467.
Beyth N, Yudovin-Farber I, Bahir R, Domb AJ, Weiss EI. Antibacterial activity of dental composites containing quaternary ammonium polyethylenimine nanoparticles against Streptococcus mutans. Biomaterials. 2006 Jul;27(21):3995-4002. doi: 10.1016/j.biomaterials.2006.03.003. Epub 2006 Mar 27.
Beyth N, Houri-Haddad Y, Baraness-Hadar L, Yudovin-Farber I, Domb AJ, Weiss EI. Surface antimicrobial activity and biocompatibility of incorporated polyethylenimine nanoparticles. Biomaterials. 2008 Nov;29(31):4157-63. doi: 10.1016/j.biomaterials.2008.07.003. Epub 2008 Aug 3.
Beyth N, Yudovin-Fearber I, Domb AJ, Weiss EI. Long-term antibacterial surface properties of composite resin incorporating polyethyleneimine nanoparticles. Quintessence Int. 2010 Nov-Dec;41(10):827-35.
Chatzistavrou X, Velamakanni S, DiRenzo K, Lefkelidou A, Fenno JC, Kasuga T, Boccaccini AR, Papagerakis P. Designing dental composites with bioactive and bactericidal properties. Mater Sci Eng C Mater Biol Appl. 2015;52:267-72. doi: 10.1016/j.msec.2015.03.062. Epub 2015 Mar 28.
Rechmann P, Le CQ, Chaffee BW, Rechmann BMT. Demineralization prevention with a new antibacterial restorative composite containing QASi nanoparticles: an in situ study. Clin Oral Investig. 2021 Sep;25(9):5293-5305. doi: 10.1007/s00784-021-03837-4. Epub 2021 Feb 19.
Study Start
May 28, 2019
Actual (reported)Primary Completion
March 10, 2020
Actual (reported)Study Completion
March 10, 2020
Actual (reported)Last Updated
March 12, 2021
Results First Posted
March 12, 2021
Record last verified: 2021-03
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